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• W2292267427 abstract "In patients with a small aortic root undergoing aortic valve replacement (AVR), the Freedom SOLO bioprosthesis may be the ideal prosthesis because of its stentless design and supra-annular implantation. This study investigated if the stentless Freedom SOLO has an advantage when compared with a stented bioprosthesis in patients with a small aortic root. From April 2005-July 2014, 269 consecutive patients underwent AVR with either a Freedom SOLO (n = 76) or Mitroflow (n = 193) bioprosthesis size 19 mm or 21 mm, respectively. This retrospective comparison study presents clinical and echocardiographic follow-up data. In results, operative outcome and survival were similar. At 7 years, cumulative incidence of aortic valve reoperation and structural valve deterioration favor the Freedom SOLO (0% vs 7.1%, P = 0.03 and 0% vs 4.5%, P = 0.08, respectively). Additionally, the postoperative peak and mean valvular gradients favor the Freedom SOLO (21 ± 9 mm Hg vs 32 ± 12 mm Hg and 12 ± 5 mm Hg vs 19 ± 8 mm Hg, both P = <0.001, respectively). During mid-term follow-up this hemodynamic advantage continued in favor of the Freedom SOLO. Also prosthesis-patient mismatch occurred less frequently in the Freedom SOLO (28% vs 52%, P = 0.001). There were no differences in prosthetic valve endocarditis, thromboembolic, or bleeding events. In conclusion, the stentless Freedom SOLO has several significant advantages for AVR in patients with a small aortic root in comparison with a stented Mitroflow bioprosthesis. The Freedom SOLO shows superior hemodynamic performance with significantly lower valvular gradients that remained stable during mid-term follow-up. Additionally, significantly fewer prosthesis-patient mismatch occurred and the Freedom SOLO showed superior durability. In patients with a small aortic root undergoing aortic valve replacement (AVR), the Freedom SOLO bioprosthesis may be the ideal prosthesis because of its stentless design and supra-annular implantation. This study investigated if the stentless Freedom SOLO has an advantage when compared with a stented bioprosthesis in patients with a small aortic root. From April 2005-July 2014, 269 consecutive patients underwent AVR with either a Freedom SOLO (n = 76) or Mitroflow (n = 193) bioprosthesis size 19 mm or 21 mm, respectively. This retrospective comparison study presents clinical and echocardiographic follow-up data. In results, operative outcome and survival were similar. At 7 years, cumulative incidence of aortic valve reoperation and structural valve deterioration favor the Freedom SOLO (0% vs 7.1%, P = 0.03 and 0% vs 4.5%, P = 0.08, respectively). Additionally, the postoperative peak and mean valvular gradients favor the Freedom SOLO (21 ± 9 mm Hg vs 32 ± 12 mm Hg and 12 ± 5 mm Hg vs 19 ± 8 mm Hg, both P = <0.001, respectively). During mid-term follow-up this hemodynamic advantage continued in favor of the Freedom SOLO. Also prosthesis-patient mismatch occurred less frequently in the Freedom SOLO (28% vs 52%, P = 0.001). There were no differences in prosthetic valve endocarditis, thromboembolic, or bleeding events. In conclusion, the stentless Freedom SOLO has several significant advantages for AVR in patients with a small aortic root in comparison with a stented Mitroflow bioprosthesis. The Freedom SOLO shows superior hemodynamic performance with significantly lower valvular gradients that remained stable during mid-term follow-up. Additionally, significantly fewer prosthesis-patient mismatch occurred and the Freedom SOLO showed superior durability. Central MessageThe stentless Freedom SOLO has several significant advantages for AVR in patients with a small aortic root in comparison with a stented Mitroflow bioprosthesis. Therefore, in patients with a small aortic root, the stentless Freedom SOLO should be considered. The stentless Freedom SOLO has several significant advantages for AVR in patients with a small aortic root in comparison with a stented Mitroflow bioprosthesis. Therefore, in patients with a small aortic root, the stentless Freedom SOLO should be considered. Perspective StatementThis single-center retrospective study investigated if the stentless Freedom SOLO bioprosthesis has an advantage when compared with a stented Mitroflow bioprosthesis in 269 patients with a small aortic root. The Freedom SOLO shows superior hemodynamic performance, fewer prosthesis-patient mismatch, and superior durability during mid-term follow-up. This single-center retrospective study investigated if the stentless Freedom SOLO bioprosthesis has an advantage when compared with a stented Mitroflow bioprosthesis in 269 patients with a small aortic root. The Freedom SOLO shows superior hemodynamic performance, fewer prosthesis-patient mismatch, and superior durability during mid-term follow-up. In patients with a small aortic root undergoing aortic valve replacement (AVR), operative mortality is increased.1Wilbring M. Alexiou K. Schumann E. et al.Isolated aortic valve replacement in patients with small aortic annulus-a high-risk group on long-term follow-up.Thorac Cardiovasc Surg. 2013; 61: 379-385Crossref PubMed Google Scholar Additionally, there is an increased risk for prosthesis-patient mismatch, which is undesirable as it is associated with decreased hemodynamic function, less regression of left ventricular mass, more cardiac events, and worse survival.2Pibarot P. Dumesnil J.G. Prosthesis-patient mismatch: definition, clinical impact, and prevention.Heart. 2006; 92: 1022-1029Crossref PubMed Scopus (405) Google Scholar Surgical aortic annulus dilatation is an option, but this extends operation time and requires an experienced surgeon.3Nicks R. Cartmill T. Bernstein L. Hypoplasia of the aortic root. The problem of aortic valve replacement.Thorax. 1970; 25: 339-346Crossref PubMed Scopus (225) Google Scholar, 4Manouguian S. Seybold-Epting W. Patch enlargement of the aortic valve ring by extending the aortic incision into the anterior mitral leaflet. New operative technique.J Thorac Cardiovasc Surg. 1979; 78: 402-412Abstract Full Text PDF PubMed Google Scholar Patients with a small aortic root may profit from the implantation of a stentless bioprostheses as its design provides a larger effective orifice area. This leads to less prosthesis-patient mismatch, lower valvular gradients, and better postoperative outcomes.5Gulbins H. Reichenspurner H. Which patients benefit from stentless aortic valve replacement?.Ann Thorac Surg. 2009; 88: 2061-2068Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar The Freedom SOLO (Sorin, Saluggia, and Italy) is a stentless bioprosthesis with an excellent hemodynamic profile and cross-clamp times that are equal to stented bioprostheses.6Wollersheim L.W. Li W.W. Bouma B.J. et al.Aortic valve replacement with the stentless Freedom SOLO bioprosthesis: A systematic review.An Thorac Surg. 2015; 100: 1496-1504Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar Its stentless design and supra-annular implantation technique offers the largest possible effective orifice area. This study investigates if the stentless Freedom SOLO has advantages over a stented bioprosthesis in patients with a small aortic root. We hypothesize that in patients with a small aortic root the hemodynamic performance of the Freedom SOLO is better than that of a stented bioprosthesis. Between June 2005 and July 2014, 269 consecutive patients underwent AVR with either a stentless Freedom SOLO or a stented Mitroflow (Sorin, Saluggia, and Italy) with a size 19 mm or 21 mm prosthesis. Both manufacturers׳ 19 mm and 21 mm sizers are comparable in diameter. The Mitroflow prostheses were implanted supraannular. All operations were performed at the Academic Medical Center in Amsterdam, The Netherlands. The choice of prosthesis was based on surgeon׳s preference and made in consultation with the patient. Baseline patient characteristics, operative details, and in-hospital complications were collected from the Academic Medical Center database. On January 6, 2015, information on vital status was obtained from the Dutch national population registry (Statistics Netherlands, Voorburg, The Netherlands). Follow-up data and echocardiographic results were collected retrospectively, during visits to the referring cardiology centers. Patients were censored at time of last contact. The Society of Thoracic Surgeons Adult Cardiac Surgery Database Data Specifications, version 2.81, was used for definitions of baseline characteristics and postoperative outcome.7STS Adult Cardiac Surgery Database Data Specifications, version 2.81. 〈http://www.sts.org/sts-national-database/database-managers/adult-cardiac-surgery-database/data-collection〉.Google Scholar Mortality was defined as 30-day and in-hospital mortality combined. Preoperative renal failure was defined as a calculated creatinine clearance <50 mL/min using the Cockcroft-Gault formula.8Cockcroft D.W. Gault M.H. Prediction of creatinine clearance from serum creatinine.Nephron. 1976; 16: 31-41Crossref PubMed Scopus (13131) Google Scholar For definitions of structural valve deterioration, nonstructural dysfunction, embolism, bleeding event, endocarditis, and aortic valve reoperation; the guidelines for reporting mortality and morbidity after cardiac valve interventions were used.9Akins C.W. Miller D.C. Turina M.I. et al.Guidelines for reporting mortality and morbidity after cardiac valve interventions.J Thorac Cardiovasc Surg. 2008; 135: 732-738Abstract Full Text Full Text PDF PubMed Scopus (495) Google Scholar Prosthesis-patient mismatch was defined as an indexed effective orifice area <0.85 cm2/m2,2Pibarot P. Dumesnil J.G. Prosthesis-patient mismatch: definition, clinical impact, and prevention.Heart. 2006; 92: 1022-1029Crossref PubMed Scopus (405) Google Scholar measured with transthoracic echocardiography within 2 years postoperatively. Since 2010, all patients received oral anticoagulation therapy for 3 months postoperatively followed by lifelong acetylsalicylate 100 mg daily. From 2010, all patients received only lifelong antiplatelet therapy with acetylsalicylate 100 mg daily unless otherwise indicated by concomitant morbidities. Data are expressed as means ± standard deviations, medians with interquartiles or as numbers and percentiles as appropriate. Differences in baseline characteristics, operative details, and outcomes were tested for significance by unpaired t-test, Mann-Whitney U test, Fisher׳s exact test, and χ2 (for trends) as appropriate. Survival, prosthetic valve endocarditis, thromboembolism, and bleeding events were analyzed using the Kaplan-Meier method. The log-rank test was used to test for differences. Aortic valve reoperation and structural valve deterioration were analyzed using cumulative incidence function using a competing risk analysis.10Grunkemeier G.L. Furnary A.P. Wu Y. et al.Durability of pericardial versus porcine bioprosthetis heart valves.J Thorac Cardiovasc Surg. 2012; 144: 1381-1386Abstract Full Text Full Text PDF PubMed Scopus (61) Google Scholar For aortic valve reoperation “death” was considered a competing risk. For structural valve deterioration both “death” and “aortic valve reoperation” were considered a competing risk. Gray׳s log-rank test was used to test for differences between the groups in the competing risk analysis. Logistic regression analysis was used to identify if choice of prosthesis was a risk factor for prosthesis-patient mismatch, considering age, sex, and body mass index as variables. The longitudinal follow-up of echocardiographic results were analyzed using a mixed effects model. Statistical analyses were performed using SPSS, version 21 (IBM Corp, Armonk, NY). The cumulative incidence function analysis and the mixed effects model were performed using R (R Foundation for Statistical Computing, Vienna, Austria). A P value of <0.05 was considered statistically significant. Baseline patient characteristics are presented in Table 1. In all, 76 patients received a Freedom SOLO and 193 patients received a Mitroflow bioprosthesis. Baseline characteristics were similar with the exception of New York Heart Association (NYHA) class and previous cerebro vascular accident. There were more patients in NYHA class III and IV in the Freedom SOLO group than in the Mitroflow group (75% vs 53%, P = 0.001), and there were more patients who had a previous cerebro vascular accident in the Mitroflow group than in the Freedom SOLO group (8% vs 1%, P = 0.04). The European System for Cardiac Operative Risk Evaluation (EuroSCORE) in both groups was comparable.Table 1Baseline Patient CharacteristicsCharacteristicFreedom SOLO (N = 76)Mitroflow (N = 193)PAge (mean ± SD)76 ± 775 ± 60.41Male, %7 (9)33 (17)0.10NYHA0.001*Significantly different. Class I/II, %19 (25)90 (47) Class III/IV, %56 (75)102 (53)BMI (mean ± SD)27.4 ± 5.426.7 ± 40.27BSA (mean ± SD)1.81 ± 0.21.82 ± 0.20.57Diabetes, %25 (33)54 (28)0.43Hypertension, %52 (68)127 (66)0.68Dyslipidemia, %46 (61)106 (55)0.40COPD, %15 (20)32 (17)0.54PVD, %7 (9)28 (15)0.25Previous MI/recent MI, %12 (16)/5 (7)33 (17)/5 (3)0.80/0.12Previous CVA/previous TIA, %1 (1)/8 (11)15 (8)/13 (7)0.04*Significantly different./0.30Renal failure, %17 (22)42 (22)0.93Reoperation, %3 (4)12 (6)0.47Endocarditis, %3 (4)6 (3)0.73Operation indication0.18 Aortic stenosis, %60 (79)134 (69) Aortic insufficiency, %1 (1)10 (5) Mixed stenosis and insufficiency, %15 (20)49 (25)Preoperative LVEF0.69 LVEF >50%, %66 (87)156 (81) LVEF 30%-50%, %9 (12)32 (17) LVEF <30%, %1 (1)3 (2)Preoperative LVOT (mean ± SD)20.5 ± 1.120.6 ± 1.20.47EuroSCORE I (mean ± SD)7.7 ± 2.27.8 ± 2.10.79EuroSCORE II (median and interquartile)3.1, 1.7-5.32.8, 1.9-5.10.68Logistic EuroSCORE (mean ± SD)10.5 ± 10.810.6 ± 10.30.95Emergency operation, %1 (1)1 (1)0.49BMI, body mass index; BSA, body surface area; COPD, chronic obstructive pulmonary disease; CVA, cerebro vascular accident; LVEF, left ventricular ejection fraction; LVOT, left ventricular outflow tract; MI, myocardial infarction; PVD, peripheral vascular disease; TIA, transient ischemic attack. Significantly different. Open table in a new tab BMI, body mass index; BSA, body surface area; COPD, chronic obstructive pulmonary disease; CVA, cerebro vascular accident; LVEF, left ventricular ejection fraction; LVOT, left ventricular outflow tract; MI, myocardial infarction; PVD, peripheral vascular disease; TIA, transient ischemic attack. Perioperative data and early clinical outcomes were presented in Table 2. In both groups, 9% of patients received a 19 mm prosthesis and the remaining 91% a 21 mm prosthesis. In the Mitroflow group there were 6 (3%) patients who underwent an aortic root enlargement resulting in 5 implantations of 21 mm bioprosthesis and 1 implantation of 19 mm bioprosthesis. Cross-clamp time for isolated AVR was 84 ± 24 minutes for the Freedom SOLO and 82 ± 24 minutes for the Mitroflow (P = 0.65). There were no significant differences between the 2 groups regarding mortality, cerebro vascular accidents, and intensive care unit stay. Most of the patients (79%) were discharged to their referring cardiology center. The Freedom SOLO patients who were discharged home had a total length of hospital stay of 10 ± 3 days and the Mitroflow patients of 14 ± 8 days (P = 0.12). In the Freedom SOLO group, there were more patients with a postoperative platelet count <50 × 10E9/L than in the Mitroflow group (39% vs 7%, P = <0.001). This had no clinical consequences, as there were no differences in reoperation for delayed tamponade, gastrointestinal bleeding, or platelet transfusions.Table 2Perioperative Data And Early OutcomesPerioperative data and early outcomesFreedom SOLO (N = 76)Mitroflow (N = 193)PProsthesis size0.92 19 mm, %7 (9)17 (9) 21 mm, %69 (91)176 (91)Concomitant procedure, %28 (37)83 (43)0.36 CABG2573 MVP27 MVR11 Other310Cardiopulmonary bypass time (mean ± SD)128 ± 48139 ± 580.13Cross-clamp time (mean ± SD)97 ± 3598 ± 370.78Cross-clamp time isolated AVR (mean ± SD)84 ± 2482 ± 240.65Mortality, %4 (5)15 (8)0.47Mortality isolated AVR, %1 (2)7 (6)0.26CVA, %0 (0)6 (3)0.19TIA, %1 (1)1 (1)0.49Reoperation for bleeding, %11 (15)16 (8)0.13Renal failure, %7 (9)21 (11)0.69 Temporary renal replacement therapy2 (3)6 (3)0.84Pacemaker, %2 (3)8 (4)0.56Pneumonia, %3 (4)7 (4)0.90New-onset atrial fibrillation, %26 (34)74 (38)0.53Sternal wound infection, %2 (3)4 (2)0.78Lowest platelet count69 ± 35101 ± 39<0.001*Significantly different.Reoperation for delayed tamponade, %2 (3)7 (4)0.68Gastrointestinal bleeding event, %1 (1)4 (2)0.68RBC after OR N, %24 (32)52 (27)0.45Thrombocyte transfusion after OR N, %8 (11)17 (9)0.66ICU stay (median and interquartile)1, 1-32, 1-20.37LOS for patient discharged home (mean ± SD)10 ± 314 ± 80.12Prosthesis-patient mismatch19 (28)91 (52)0.001*Significantly different.Pmax at discharge (mean ± SD)21 ± 932 ± 12<0.001*Significantly different.Pmean at discharge (mean ± SD)12 ± 519 ± 8<0.001*Significantly different.EOA at discharge (mean ± SD)1.89 ± 0.491.42 ± 0.46<0.001*Significantly different.CABG, coronary artery bypass graft; CVA, cerebro vascular accident; EOA, effective orifice area; ICU, intensive care unit; LOS, length of hospital stay; LVEF, left ventricular ejection fraction; MVP, mitral valve repair; MVR, mitral valve replacement; N, number; OR, operation; Pmax, maximum valvular gradient; Pmean, mean valvular gradient; RBC, red blood cells; TIA, transient ischemic attack. Significantly different. Open table in a new tab CABG, coronary artery bypass graft; CVA, cerebro vascular accident; EOA, effective orifice area; ICU, intensive care unit; LOS, length of hospital stay; LVEF, left ventricular ejection fraction; MVP, mitral valve repair; MVR, mitral valve replacement; N, number; OR, operation; Pmax, maximum valvular gradient; Pmean, mean valvular gradient; RBC, red blood cells; TIA, transient ischemic attack. The mean and median clinical follow-up for the Freedom SOLO were 4.0 ± 2.5 (range: 0.2-9.5 years) and 3.7 years (interquartile: 1.9-6.1 years), respectively. The mean and median clinical follow-up for the Mitroflow were 3.6 ± 2.4 (range: 0.1-9.1 years) and 3.0 years (interquartile: 1.7-5.3 years), respectively. Totally, 3 (1.1%) patients from the Mitroflow group were lost to follow-up. Survival is presented in Figure 1 and is similar in both groups (P = 0.47). The 1-year, 5-year, and 9-year overall survival in the Freedom SOLO group was 95%, 83%, and 59%, respectively. The 1-year, 5-year, and 9-year overall survival in the Mitroflow group was 90%, 74%, and 51%, respectively. At 7 years, the cumulative incidence function probability for aortic valve reoperation was 0% for the Freedom SOLO and 7.1%for the Mitroflow (95% CI: 1.6%-12.6%, P = 0.03) (Fig. 2A). In the Mitroflow group 10 patients (1 19 mm and 9 21 mm) underwent reoperation, with a median time of 2.5 years (interquartile = 0.1-6.5 years) to reoperation. The reasons for reoperation were structural valve deterioration in 5 patients, prosthetic valve endocarditis in 3 patients, paravalvular leakage in 1 patient and immediate technical failure with a high-valvular gradient, and paravalvular leakage in 1 patient. In all, 5 patients who underwent reoperation received a new Mitroflow, 3 patients a Freedom SOLO, 1 an Edwards Perimount (Edwards Lifesciences, Irvine, CA), and 1 patient underwent a transcatheter aortic valve implantation with a CoreValve (Medtronic, Minneapolis, MS). Of the 3 Freedom SOLO prostheses 2 were one size larger than the original Mitroflow and 1 Freedom SOLO was 1 size smaller than the original Mitroflow. Also at 7 years, the cumulative incidence function probability for structural valve deterioration of the Freedom SOLO was 0% and of the Mitroflow 4.5% (95% CI: 0.5%-8.4%, P = 0.08) (Fig. 2B). In the Mitroflow group there were 7 patients with structural valve deterioration. Prosthetic valve endocarditis occurred in 2 patients with a Freedom SOLO (0.7% per patient year, 95% CI: 0.1-2.3) and both were treated with intravenous antibiotics. Prosthetic valve endocarditis occurred in 10 patients with a Mitroflow (1.6% per patient year, 95% CI: 0.8-2.8), 3 of whom underwent reoperation and 7 were treated with intravenous antibiotics. The difference in prosthetic valve endocarditis was not significant (P = 0.27). During follow-up, 5 thromboembolic events occurred in the Freedom SOLO group (1.7% per patient year, 95% CI: 0.6-3.8); 4 patients had a transient ischemic attack and 1 patient a pulmonary embolus. In the Mitroflow group, 24 patients had a thromboembolic event (3.8% per patient year, 95% CI: 2.5-5.5); 15 patients had a cerebro vascular accident, 7 patients had a transient ischemic attack, and 2 had a pulmonary embolus. The difference in thromboembolic events was not significant (P = 0.10). During follow-up there were 2 reported bleeding events in the Freedom SOLO group (0.7% per patient year, 95% CI: 0.1-2.3), in which 1 patient had a gastrointestinal bleed and the other patient had an episode of epistaxis. Both patients were on acetylsalicylate only. In the Mitroflow group, 15 patients had a reported bleeding event (2.4% per patient year, 95% CI: 1.4-3.8); 8 patients had a gastrointestinal bleed, 4 patients had an episode of epistaxis, 1 patient had a hemorrhagic cerebral accident, 1 patient had hematuria, and 1 patient had bleeding varicose veins. Of the 15 patients with a bleeding event, 7 were on oral anticoagulants, 7 were on acetylsalicylate only, and 1 patient was on dual antiplatelet therapy. The difference in bleeding events was not significant (P = 0.08). Postoperative echocardiographic data were presented in Table 2. The postoperative peak valvular gradient was significantly lower in the Freedom SOLO than in the Mitroflow (21 ± 9 mm Hg vs 32 ± 12 mm Hg, P = <0.001). This difference remains significant during mid-term follow-up (P = <0.001) (Fig. 3A). The postoperative mean valvular gradient was significantly lower in the Freedom SOLO group than in the Mitroflow group (12 ± 5 mm Hg vs 19 ± 8 mm Hg, P = <0.001). This difference remains significant during mid-term follow-up (P = <0.001) (Fig. 3B). In the Freedom SOLO group, overall prosthesis-patient mismatch occurred less frequently than in the Mitroflow group (28% vs 52%, P = 0.001, Table 2). On multivariate analysis, the Mitroflow prosthesis was an independent risk factor for prosthesis-patient mismatch, (odds ratio = 3.0; 95% CI: 1.9-5.6; P = 0.001).In the Freedom SOLO group 73% (N = 43) of patients were in NYHA class I, 22% (N = 13) of patients were in NYHA class II, and 5% (N = 3) of patients were in NYHA class III and IV at last follow-up. In the Mitroflow group 63% (N = 76) of patients were in NYHA class I, 18% (N = 22) of patients were in NYHA class II and 19% (N = 23) of patients were in NYHA class III and IV at last follow-up (P = 0.04) (Supplementary Fig. 1). This study showed that in patients with a small aortic root requiring AVR the stentless Freedom SOLO has 3 significant advantages, when compared with the Mitroflow stented bioprosthesis. First, both cumulative incidence function probability of aortic valve reoperation and structural valve deterioration favor the Freedom SOLO at 7-year follow-up (0% vs 7.1% and 0% vs 4.5%, respectively). Second, prosthesis-patient mismatch is less likely to occur with the Freedom SOLO (28% vs 52%), and the Mitroflow stented bioprosthesis was a significant independent risk-factor for prosthesis-patient mismatch (odds ratio = 3.0). Third, the postoperative peak and mean valvular gradients were lower in the Freedom SOLO and these differences persisted during mid-term follow-up, combined with less patients in NYHA class III and IV at last follow-up (5% vs 19%). First and second generation stentless bioprostheses require multiple suture lines leading to longer cross-clamp times than for stented bioprostheses.11Jin X.Y. Gibson D.G. Yacoub M.H. et al.Perioperative assessment of aortic homograft, Toronto stentless valve, and stented valve in the aortic position.Ann Thorac Surg. 1995; 60: S395-S401Abstract Full Text PDF PubMed Scopus (98) Google Scholar The Freedom SOLO was designed as a stentless bioprosthesis for fast implantation in the sinuses of Valsalva with a single suture line. In our study, cross-clamp time for isolated AVR was comparable in both groups (84 ± 24 vs 82 ± 24 minutes). This shows that the Freedom SOLO can be implanted within the same ischemic time as a stented bioprosthesis. Mortality was 5% for the Freedom SOLO and 8% for the Mitroflow, and in isolated AVR it was 2% for the Freedom SOLO and 6% for the Mitroflow. With regard to the median EuroSCORE II in both groups, this mortality seems quite high. Advanced age and concomitant procedures were factors that increased the EuroSCORE. Additionally, prosthesis implantation in the small aortic root is likely to be more difficult, leading to longer cross-clamp times, and thus potentially increasing operative risk. A German study by Wilbring et al1Wilbring M. Alexiou K. Schumann E. et al.Isolated aortic valve replacement in patients with small aortic annulus-a high-risk group on long-term follow-up.Thorac Cardiovasc Surg. 2013; 61: 379-385Crossref PubMed Google Scholar reported that the hospital mortality for isolated AVR in a group of 148 patients with a small aortic annulus who received either a 19 mm or 21 mm Mitroflow was 6.1%. This supports the increased operative risk of AVR in patients with a small aortic annulus. In our study, there were no differences between the 2 groups regarding early clinical outcomes, implying both bioprostheses are equally safe to implant. A randomized controlled trial showed no survival benefit at 1 year after AVR with a stentless vs a stented bioprosthesis.12Ali A. Halstead J.C. Cafferty F. et al.Are stentless valves superior to modern stented valves? A prospective randomized trial.Circulation. 2006; 114: I535-I540Google Scholar Our study also showed that the Freedom SOLO had no survival benefit when compared with a stented bioprosthesis over a follow-up period of a maximum of 9.4 years. The 9-year overall survival of the Freedom SOLO (59%) and the Mitroflow (51%) are comparable to the 10-year overall survival of 45%-54% reported in the literature in patient populations with a comparable mean age.13Eichinger W.B. Hettich I.M. Ruzicka D.J. et al.Twenty-year experience with the St. Jude medical Biocor bioprosthesis in the aortic position.Ann Thorac Surg. 2008; 86: 1204-1210Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 14Celiento M. Ravenni G. Milano A.D. et al.Aortic valve replacement with the Medtronic Mosaic bioprosthesis: A 13-year follow-up.Ann Thorac Surg. 2012; 93: 510-515Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar, 15Lorusso R. Gelsomino S. De Cicco G. et al.The Italian study on the Mitroflow postoperative results (ISTHMUS): A 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis.Eur J Cardiothorac Surg. 2011; 39: 18-26Crossref Scopus (52) Google Scholar The durability of an aortic valve bioprostheses remains an essential feature. At 7 years the cumulative incidence function probability of valve explant was approximately 3%-4% for an aortic-pericardial prosthesis and approximately 5% for an aortic-porcine prosthesis.10Grunkemeier G.L. Furnary A.P. Wu Y. et al.Durability of pericardial versus porcine bioprosthetis heart valves.J Thorac Cardiovasc Surg. 2012; 144: 1381-1386Abstract Full Text Full Text PDF PubMed Scopus (61) Google Scholar The Freedom SOLO showed an excellent 0% of cumulative incidence function probability for reoperation at 7 years in patients with a small aortic root, where the Mitroflow showed a lower cumulative incidence function probability for reoperation of 7.1%. In comparison, other studies on mid-term follow-up of the Mitroflow reported conflicting results regarding freedom from reoperation and structural valve deterioration.16Ash F.M. Heimansohn D. Doyle D. et al.Mitroflow aortic bioprosthesis 5-year follow-up: North American prospective multicenter study.Ann Thorac Surg. 2012; 94: 1198-1203Abstract Full Text Full Text PDF Scopus (28) Google Scholar, 17Sénage T. Le Tourneau T. Foucher Y. et al.Early structural valve deterioration of Mitroflow aortic bioprosthesis: Mode, incidence, and impact on outcome in a large cohort of patients.Circulation. 2014; 130: 2012-2020Crossref PubMed Scopus (155) Google Scholar At 5-year follow-up, Ash et al16Ash F.M. Heimansohn D. Doyle D. et al.Mitroflow aortic bioprosthesis 5-year follow-up: North American prospective multicenter study.Ann Thorac Surg. 2012; 94: 1198-1203Abstract Full Text Full Text PDF Scopus (28) Google Scholar reported 97% freedom from reoperation whereas Sénage et al17Sénage T. Le Tourneau T. Foucher Y. et al.Early structural valve deterioration of Mitroflow aortic bioprosthesis: Mode, incidence, and impact on outcome in a large cohort of patients.Circulation. 2014; 130: 2012-2020Crossref PubMed Scopus (155) Google Scholar reported only 92% freedom from structural valve deterioration at 3.8-year follow-up, measured using the Kaplan-Meier method. Although the durability of the Mitroflow is under debate,18Kaneko T. Gosev I. Leacche M. et al.Early structural valve deterioration of the mitroflow bioprosthesis.Circulation. 2014; 130: 1997-1998Crossref Scopus (7) Google Scholar the results of the Freedom SOLO in the small aortic root are excellent. Therefore, the combination of excellent results and a significant difference found for reoperation in favor of the Freedom SOLO supports its use in AVR in the small aortic root. Another factor that supports the use of the Freedom SOLO is its low-valvular gradients. Its supra-annular implantation technique and stentless design offer the maximum effective orifice area. In the small aortic root this design has been shown to be effective and remains effective during follow-up, with valvular gradients statistically significantly lower in the Freedom SOLO than in the Mitroflow. Furthermore, the Freedom SOLO also showed favorable valvular gradients when compared with new generation stented bioprostheses that were implanted supraannularly.19Modi A. Pousios D. Sadeque S. et al.Early in-vivo hemodynamic comparison of supra-annular aortic bioprostheses: Trifecta versus Perimount Magna Ease.J Heart Valve Dis. 2014; 23: 325-332Google Scholar The maximum effective orifice area of a Freedom SOLO means a lower risk of prosthesis-patient mismatch. Depending on patient population, severe prosthesis-patient mismatch occurs in 2%-11% and moderate prosthesis-patient mismatch occurs in 20%-70% of patients.2Pibarot P. Dumesnil J.G. Prosthesis-patient mismatch: definition, clinical impact, and prevention.Heart. 2006; 92: 1022-1029Crossref PubMed Scopus (405) Google Scholar The prevention of prosthesis-patient mismatch is desirable, as it has been associated with decreased hemodynamic function, less regression of left ventricular mass, more cardiac events, and worse survival.2Pibarot P. Dumesnil J.G. Prosthesis-patient mismatch: definition, clinical impact, and prevention.Heart. 2006; 92: 1022-1029Crossref PubMed Scopus (405) Google Scholar In a population at risk for prosthesis-patient mismatch, the Freedom SOLO shows a lower rate of 28% prosthesis-patient mismatch compared with 52% in the Mitroflow. In comparison, Jamieson et al20Jamieson W.R. Forgie W.R. Hayden R.I. et al.Hemodynamic performance of mitroflow aortic pericardial bioprosthesis—Optimizing management for the small aortic annulus.Thorac Cardiovasc Surg. 2010; 58: 69-75Crossref PubMed Scopus (25) Google Scholar showed that prosthesis-patient mismatch occurred in 60% (n = 18) in a small group of 30 patients who received either a 19 mm or 21 mm Mitroflow. Additionally, our study showed that the odds ratio of developing prosthesis-patient mismatch is 3.0 with a stented Mitroflow compared with a stentless Freedom SOLO. Both Jamieson et al1Wilbring M. Alexiou K. Schumann E. et al.Isolated aortic valve replacement in patients with small aortic annulus-a high-risk group on long-term follow-up.Thorac Cardiovasc Surg. 2013; 61: 379-385Crossref PubMed Google Scholar and Wilbring et al20Jamieson W.R. Forgie W.R. Hayden R.I. et al.Hemodynamic performance of mitroflow aortic pericardial bioprosthesis—Optimizing management for the small aortic annulus.Thorac Cardiovasc Surg. 2010; 58: 69-75Crossref PubMed Scopus (25) Google Scholar supported the use of the Mitroflow in patients with a small aortic annulus owing to good hemodynamic performance and an acceptable incidence of prosthesis-patient mismatch. Regarding valvular gradients and prosthesis-patient mismatch, the results of our study showed that the stentless Freedom SOLO is superior to the stented Mitroflow in patients with a small aortic root. One of the limitations of this study is the risk of selection bias. This is a retrospective study and prosthesis choice was made by the surgeon, both of which may induce selection bias. The retrospective nature of this study did not result in equal patient characteristics. The comparison was made with the Mitroflow bioprosthesis only because of the availability at our center. Also the groups studied were relatively small containing 269 patients in total. Additionally, 3 (1.1%) patients were lost to follow-up. There was no standard echocardiographic protocol and follow-up echocardiographs were scheduled at the same time intervals in the referring cardiology centers. Unfortunately, left ventricular mass is not included in the standard follow-up echocardiographic investigation in the Netherlands and therefore this information is missing. The stentless Freedom SOLO has several significant advantages in AVR in patients with a small aortic root when compared with a stented Mitroflow bioprosthesis. Our hypothesis is confirmed as the Freedom SOLO has shown superior hemodynamic performance with lower valvular gradients that remain stable during mid-term follow-up. Additionally, fewer prosthesis-patient mismatches occurred, less patients are in NYHA class III and IV and the Freedom SOLO shows superior durability. This makes the stentless Freedom SOLO the preferred bioprosthesis for patients with a small aortic root at our center. Additional research, preferably prospective, is needed to confirm these results in other stented bioprostheses." @default.
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